QC Equipment/CSV Specialist
Semma Therapeutics
Job Description
General Summary:
The Quality Control Senior Specialist provides a variety of analytical functions that occur in the QC department supporting validation, testing and reporting of in-process, release and stability samples. This role also works to ensure activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.
Key Duties and Responsibilities:
- Serve as RSL representative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all laboratory needs
- Coordinate and facilitate laboratory activities to meet commitments on-time
- Maintain accurate laboratory records and adhere to cGMP/GDP expectations
- Participate in planning, executing and/or review of method validations, method transfers and/or equipment qualification/requalification
- Assist in troubleshooting of analytical methods and/or equipment as required
- Authors, reviews, and/or approve data, SOPs, COAs, analytical methods, protocols and reports
- Leads compliance related teams working towards the goal of continuous improvement
- May perform in-process, release, and stability testing and/or review independently following established methodology,, procedures and SOPs
- May be required to lead the OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence
Knowledge and Skills:
- Strong knowledge of US and EU cGMP regulations/guidance and some experience with regulatory agency inspections
- Strong knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements.
- The ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects is essential.
- Strong attention to detail
- Effective communication skills, both verbal and written.
Education and Experience:
- Bachelor's Degree in science or related discipline is required.
- 2+ years of experience in GMP pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience
#LI- Onsite
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.